Device product
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Z-2276-2025
Product summary
- Event
- Event 97127
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,640 pieces
- Official record key
device-enforcement:Z-2276-2025
Official wording
Reason: Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
Code information: Model Number: 1113090. UDI-DI (Case): 05030267153961, UDI-DI (Single Unit): 5030267050680. Lot Number: 32420657
Distribution pattern: US distribution to AZ, CA, CT, FL, FL, HI, MA, MI, OH, UT, VA.
Derived failure modes
-
Unknown
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.